Expert group meeting on the safety profile of injectable artesunate

This meeting brought together representatives from various organizations to discuss the safety profile of injectable artesunate. The following recommendations were made:

The report from this meeting should be shared for review by the WHO Technical Expert Group which is updating the Malaria Treatment Guidelines.

Physicians need to be made aware of the possibility of delayed haemolysis after injectable artesunate for severe malaria, and the need for continued monitoring of patients, particularly those with high pre-treatment parasitaemia. However, the high clinical benefits of artesunate should be emphasised compared to quinine to ensure the continued use and further adoption of injectable artesunate as a life-saving treatment in severe malaria.

For data to be comparable across clinical studies, a consistent definition of delayed haemolytic anaemia and of severe malaria is required.

Mechanistic studies on the effect of artesunate on erythrocyte production, destruction and regeneration should aim to result in measures that improve clinical outcomes.

Prospective clinical trials need to be conducted in different patient populations. The objective of clinical studies should be to define the frequency of delayed anaemia, identification of prognostic factors and to examine interventions that may reduce the frequency of delayed anaemia. This includes determining the appropriate ACT dose suitable as follow on therapy following multiple doses of injectable artesunate to assess if there is a dose–response relationship with post-treatment delayed anaemia.